TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION FOR PATIENTS WITH LOW-BACK PAIN: A RANDOMIZED CONTROLLED

Setchenkova N. Transcutaneous electrical nerve stimulation for patients with low-back pain: a pilot randomized controlled clinical trial/ N. Setchenkova, L. Akhmadeeva, A. Bulgakova, E. Abdrashitova // Jornal of rehabilitation medicine. - 2008. - №47 - р. 96.

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION FOR PATIENTS WITH LOW-BACK PAIN: A PILOT RANDOMIZED CONTROLLED CLINICAL TRIAL

N. Setchenkova, L. Akhmadeeva, A. Bulgakova, E. Abdrashitova
Bashkir State Medical University, Ufa, Russia

Transcutaneous electrical nerve stimulation (TENS) is a modality known for 30 years as an additional way of management of low back pain (LBP), but randomized controlled clinical trials (RCT) are still lacking (A. Khadilkar et al, 2005). One of the most frequently used devices for TENS in Russia is DiaDENS-PKM. The aim of our study is to determine pain reduction after TENS in patients with LBP. The study was supported by DENAS MC Corporation (Russia).

Methods: We used DiaDENS-PKM (DENS) and placebo device made by manufacturer as an additional modality to standard protocol. LBP in these patients was non-specific; disc herniations, tumors and other known causes were excluded before inviting patients for the study. Randomization was made by an independent expert using computer software. During 7 months we performed screening for non-specific LBP in 1566 in-patients with all types of non-surgical disorders in our University hospital. It was suggested to participate in this study to 48 patients who fulfilled inclusion criteria and we obtained informed consent confirming their willingness to participate from 30 patients. They were randomized into DENS group (15 patients) and placebo group (15 patients). Each patient got 7–10 procedures 20 minutes each. For DENS we used 77 Hz (5 min.), 20 Hz (5 min) and 77–10 Hz (10 min). The study was single blind — patients were not informed which group they belong to. Six patients from each group left the study for different reason not related to their health or effects of the trial. Visual analogue scale (VAS) and Oswestry disability index (ODI) were used for assessment of pain and disability.

Results: All patients had reduction of their pain during the study but VAS in DENS patients was significantly lower beginning with day 7 (р<0,05). ODI was calculated in both groups before and after the study. In DENS group it was 37,6±4,7 and 26,8±4,8 accordingly (p0,05). No side effects were registered.

Conclusion: The first results of our pilot RCT show TENS as a promising adjunct in management of LBP. The study has to be continued and to include more patients.